Datascope recalls Sensation Plus 7.5Fr 40cc Intra-Aortic Balloon Catheters with expired label due to reversed manufacture and expiry dates. Affected units may be used incorrectly.
The device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured.
Datascope is recalling Sensation Plus 7.5Fr 40cc Intra-Aortic Balloon Catheters with accessories because the outer carton labels show the product as expired before it was made. This could lead to improper use if the catheter is used without proper validation of its date.
The catheter's outer carton has labels with the manufacture date and expiry date reversed. This means the product appears expired before it was actually manufactured. If used without verifying the correct dates, it could lead to improper use in critical cardiac procedures.
Healthcare professionals who use this catheter for cardiac assist therapy may be affected. Patients receiving this device during procedures are at risk if the label error causes incorrect use.
Check for the outer carton labeled with the product name 'Sensation Plus 7.5Fr 40cc Intra-Aortic Balloon Catheter with accessories'. Look for lot codes: 3000082472, 3000084069, 3000085231, 3000086994, 3000087688, 3000091205, 3000091206, or 3000091828.
Verify the outer carton's manufacture and expiry dates are not reversed.
The outer carton labels show the product as expired before it was manufactured due to reversed date labels.
The recall record does not specify a remedy, so check the label dates to ensure they are not reversed.
Look for the lot codes: 3000082472, 3000084069, 3000085231, 3000086994, 3000087688, 3000091205, 3000091206, or 3000091828.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1966-2019 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1966-2019 from Datascope. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
